Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty

Summary

This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications.

A total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery.

The primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance.

Research-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and/or dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation.

This study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.

Conditions

• Wound Surgical
• Diabetes
• Obesity
• Chronic Kidney Diseases
• Smoking

Interventions

DEVICE

NP Seal

Designed to maintain negative pressure without an external battery-powered pump or canister.

DEVICE

PICO

Designed to deliver negative pressure for up to 7 days and has visual alerts for issues such as air leaks, low battery, or dressing change

DEVICE

Prevena

Designed to deliver continuous negative pressure over the closed incision and collect fluid in a separate canister.

Sponsors & Collaborators

• Stryker Instruments

  collaborator INDUSTRY

• The Cleveland Clinic

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-12-31

Completion

2030-12-31

FDA Device

Yes